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FDA Approves Nivolumab Plus Ipilimumab for First-Line Metastatic NSCLC with PD-L1 Tumour Expression ≥1%

FDA also approved the PD-L1 IHC 28-8 pharmDx as a companion diagnostic device
25 May 2020
Cancer Immunology and Immunotherapy;  Lung and other thoracic tumours

On 15 May 2020, the US Food and Drug Administration (FDA) approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1 ≥1%, as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.

The FDA also approved the PD-L1 IHC 28-8 pharmDx (Agilent Technologies, Inc.) as a companion diagnostic device for selecting patients with NSCLC for treatment with nivolumab plus ipilimumab.

Efficacy was investigated in CHECKMATE-227 (NCT02477826), a randomised, open-label, multi-part trial in patients with metastatic or recurrent NSCLC and no prior anticancer therapy. In Part 1a of the trial, 793 patients with PD-L1 tumour expression ≥1% were randomised to receive either the combination of nivolumab plus with ipilimumab (n=396) or platinum-doublet chemotherapy (n=397).

The trial demonstrated a statistically significant improvement in overall survival (OS) for patients with PD-L1 tumour expression ≥1% receiving nivolumab plus ipilimumab compared to those treated with platinum-doublet chemotherapy. Median OS was 17.1 months (95% confidence interval [CI] 15, 20.1) versus 14.9 (95% CI 12.7, 16.7) (hazard ratio [HR] 0.79; 95% CI 0.67, 0.94; p = 0.0066).

Median progression-free survival per blinded independent central review (BICR) was 5.1 months (95% CI 4.1, 6.3) in the nivolumab plus ipilimumab arm and 5.6 months (95% CI 4.6, 5.8) in the platinum-doublet chemotherapy arm (HR 0.82; 95% CI 0.69, 0.97).

Confirmed overall response rate per BICR was 36% (95% CI 31, 41) and 30% (95% CI 26, 35), respectively.

Median response duration was 23.2 months in the nivolumab plus ipilimumab arm and 6.2 months in the platinum-doublet chemotherapy arm.

The most common adverse reactions in ≥20% of patients receiving the combination of nivolumab plus ipilimumab in CHECKMATE-227 were fatigue, rash, decreased appetite, musculoskeletal pain, diarrhoea/colitis, dyspnoea, cough, pruritis, nausea, and hepatitis.

The recommended doses for metastatic NSCLC are nivolumab 3 mg/kg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.

Full prescribing information for OPDIVO is available here.

Full prescribing information for YERVOY is available here.

This application was granted priority review.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting Systems.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate. 

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